In the notice with the above heading published in the New Zealand Gazette, 12 November 2009, No. 164, page 3972, the entry for Priligy is to be deleted from Full Consent section 20, and be placed in Provisional Consent section 23 as hereunder:
Provisional Consent to the Distribution of a New Medicine
Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Schedule
Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 67.2mg equivalent to 60mg dapoxetine
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Mamey Ward, Gurabo, Puerto Rico
Note: This consent is valid for two years from 12 November 2009.
Dated this 4th day of June 2010.
STEWART JESSAMINE, Acting Deputy Director-General, Regulation and Governance Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).